How can the actions of users be enabled?
It is only possible to start to design information after the users, the actions, and the performance levels have been established. The aim of a design is ‘to enable the users to act appropriately’. (This is the exact phrase that is used in the EU-legislation: Directive 2204/27/EU, article 63).
An information design approach is based on direct contacts with people who will use specific information. These dialogues, interviews, and observations provide a rich source of evidence that can be used to develop different prototypes.
Prototypes are tangible and visible presentations of information on screens, on packaging, in leaflets, in both digital and analogue formats.
The development and testing of each of these formats requires a range of skills. Writers, editors, graphic designers, information designers, user-interface designers, usability testers, and programmers are just a few of the required professions that might be involved in the development of prototypes.
This development is certainly an iterative process of developing, making, trying, and testing.
There are at least five, and probably more ways to enable people to do things:
- Design information (make sure that the information can be accessed and applied)
- Design a product (make sure that the pharmaceutical form can be used)
- Design education and training (make sure that the actions are understood and can be executed)
- Design a process (make sure that the information and situation/context are integrated)
- Design a system (make sure that the system of production, distribution, dispensing, delivery, administration suits the different users)
It is clear that not every medicine needs a combination of these five ways of enabling. There is not a single solution that would suit all medicines.
The principles of good information design start from the idea that there are many different ways to enable people to act. It is essential to provide different types of information, on different levels of detail, in different formats to increase the probability that users can access and understand information.
Before this principle can be applied to the development of information about medicines, it is essential to allow for the development of prototypes. It must be possible to divert from the current templates and guidelines when the information effectively enables users to act appropriately.
It is very unlikely that a design approach will lead to a printed package insert only. Printed information on paper remains important, but only as a part in a larger information strategy. It is also very unlikely that – in order to enable users to act appropriately – that there is a single information strategy that suits all users, all actions, and all medicines.
Providing information about medicines to people is just as much a ‘tailor made solution’ as providing medicines to people. Not every patient gets the same medicine, so why should we give all patients identically structured information in the same format?
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This principle needs to be applied to the development of Guidelines and templates too. The current format of Adobe pdf’s for the Readability Guideline, and a Microsoft Word for a template are not really suitable for an optimal integration into the workflow of either MAHs or Regulatory authorities. It seems essential to – after establishing users, actions, and performance levels – develop prototypes that really enable MAHs and Regulatory authorities to design and control information that ‘enables users to act appropriately’.